{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Des Plaines",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91286",
      "recalling_firm": "Abbott Molecular, Inc.",
      "address_1": "1300 E Touhy Ave",
      "address_2": "N/A",
      "postal_code": "60018-3315",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "x",
      "recall_number": "Z-1009-2023",
      "product_description": "Alinity m System.      The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.",
      "product_quantity": "918 units",
      "reason_for_recall": "The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1.  Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration.  2.  Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration.  3.  Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.",
      "recall_initiation_date": "20221209",
      "center_classification_date": "20230120",
      "report_date": "20230201",
      "code_info": "Model Number: 08N53-002",
      "more_code_info": ""
    }
  ]
}